D-SPECT Scanner, D-SPECT L Scanner— 510(k) K161740
Substantially EquivalentSpectrum Dynamics Medical, Ltd.
FDA 510(k) clearance K161740 for D-SPECT Scanner, D-SPECT L Scanner, Substantially Equivalent on 2016-11-04. Applicant: Spectrum Dynamics Medical, Ltd.. Device class: 2.
Clearance details
- Applicant
- Spectrum Dynamics Medical, Ltd.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Industrial Park. Caesarea, IL
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Data sourced from openFDA. This site is unofficial and independent of the FDA.